Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Rules and Regulations 17397 

support of its assertion, FDA is denying 

the request for a hearing on this point 

because a hearing will not be granted on 

the basis of mere allegations or denials 

or general descriptions of positions and 

contentions (21 CFR 12.24(b)(2)). 

(5) Public Citizen asserts that by FDA 

failing to comply with § 170.22, FDA 

did not comply with § 170.20 (21 CFR 

170.20), which states that ‘‘the 

Commissioner will be guided by the 

principles and procedures for 

establishing the safety of food additives 

stated in current publications of the 

National Academy of Sciences National 

Research Council.’’

Section 170.22 pertains to safety 

factors to be applied to animal 

experimentation data in determining 

whether a proposed use of a food 

additive is safe. As discussed previously 

in item 4, no animal studies were 

necessary nor were any conducted to 

demonstrate that the use of 7.5 MeV xrays is safe for treating food. Because the 

provisions of § 170.22 do not apply to 

the agency’s review of FAP 3M4745, 

Public Citizen’s assertion that FDA did 

not comply with § 170.20 because it did 

not comply with § 170.22 is without 

merit. Therefore, this objection is not a 

basis for a hearing because there is no 

genuine and substantial issue of fact for 

resolution (§ 12.24(b)(1)). 

(6) Public Citizen asserts that FDA did 

not comply with 21 U.S.C. 348(c)(3)(A), 

which states that ‘‘No such regulation 

shall issue if a fair evaluation of the data 

before the Secretary—(A) fails to 

establish that the proposed use of the 

food additive, under the conditions of 

use to be specified in the regulation, 

will be safe: Provided, That no additive 

shall be deemed to be safe if it is found 

to induce cancer when ingested by 

man.’’ Nor has FDA complied with 

§ 170.3(i), which defines ‘‘safe’’ as 

‘‘there is a reasonable certainty in the 

minds of competent scientists that the 

substance is not harmful under the 

intended conditions of use.’’

Public Citizen has not provided any 

evidence to support these allegations or 

that contradicts or challenges the 

agency’s safety determination. The 

agency finds that this objection is 

merely a general description of Public 

Citizen’s position, and that it does not 

raise a factual issue for resolution at a 

hearing. Therefore, FDA is denying the 

requests for a hearing on this point 

because there is no genuine and 

substantial issue of fact for resolution at 

a hearing, and a hearing will not be 

granted on the basis of mere allegations 

or denials or general descriptions of 

positions and contentions (§ 12.24(b)(1) 

and (b)(2)). 

V. Summary and Conclusions 

Section 409 of the act requires that a 

food additive be shown to be safe prior 

to marketing. Under § 170.3(i), a food 

additive is ‘‘safe’’ if there is a reasonable 

certainty in the minds of competent 

scientists that the substance is not 

harmful under the intended conditions 

of use. In the final rule approving the 

use of 7.5 MeV x-rays for treating food, 

FDA concluded, based on its evaluation 

of the data submitted in the petition and 

other relevant material, that the use of 

7.5 MeV x-rays proposed in the petition 

for treating food is safe under the 

conditions set forth in the regulation 

codified at § 179.26. The petitioner has 

the burden to demonstrate the safety of 

the additive in order to gain FDA 

approval. Once FDA makes a finding of 

safety, the burden shifts to an objector, 

who must come forward with evidence 

that calls into question FDA’s 

conclusion (American Cyanamid Co. v. 

FDA, 606 F.2d 1307, 1314–1315 (D.C. 

Cir. 1979)). 

None of the objections received 

contained evidence to support a genuine 

and substantial issue of fact. Nor has 

any objector established that the agency 

overlooked significant information in 

reaching its conclusion. Therefore, the 

agency has determined that the 

objections that requested a hearing do 

not raise any substantial issue of fact 

that would justify an evidentiary 

hearing (§ 12.24(b)). Accordingly, FDA 

is not making any changes in response 

to the objections and is denying the 

requests for a hearing. 

Dated: March 27, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–6646 Filed 4–6–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 803, 814, 820, 821, 822, 

874, 886, 1002, 1005, and 1020 

[Docket No. 2007N–0104] 

Medical Devices; Technical 

Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending 

certain medical device regulations to 

correct typographical errors and to 

ensure accuracy and clarity in the 

agency’s regulations. 

EFFECTIVE DATE: April 9, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Philip Desjardins, Center for Devices 

and Radiological Health (HFZ–215), 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850, 240–

276–2343. 

SUPPLEMENTARY INFORMATION: FDA is 

amending its regulations in parts 803, 

814, 820, 821, 822, 874, 886, 1002, 1005, 

and 1020 to correct typographical errors, 

and update addresses, telephone 

numbers, and wording to ensure 

accuracy and clarity in the agencies 

medical device regulations. 

Publication of this document 

constitutes final action on these changes 

under the Administrative Procedure Act 

(5 U.S.C. 553). FDA has determined that 

notice and public comment are 

unnecessary because these errors are 

nonsubstantive. 

I. Highlights of the Final Rule 

FDA is making changes to correct 

typographical and other minor errors in 

certain device regulations in parts 803, 

814, 820, 821, 822, 874, 886, 1002, 1005, 

and 1020 (21 CFR 803, 814, 820, 821, 

822, 874, 886, 1002, 1005, and 1020). 

1. FDA is revising § 803.11 and 

replacing ‘‘301–443–8818’’ with ‘‘240–

276–3151.’’

2. FDA is revising § 803.11 and 

replacing ‘‘http://www.fda.gov/cdrh/ 

mdr/mdr-forms.html’’ with ‘‘http:// 

www.fda.gov/medwatch/getforms.htm.’’

3. FDA is revising § 803.21(a) and 

replacing ‘‘301–443–8818’’ with ‘‘240–

276–3151.’’

4. FDA is revising § 803.21(a) and 

replacing ‘‘http://www.fda.gov/cdrh/ 

mdr/373.html’’ with ‘‘http:// 

www.fda.gov/cdrh/mdr/mdrforms.html.’’

5. FDA is revising § 814.20(g) and 

replacing ‘‘FDA has issued a PMA 

guidance document to assist the 

applicant in the arrangement and 

content of a PMA. This guidance 

document is available on the Internet at 

http://www.fda.gov/cdrh/dsma/ 

pmaman/front.html. This guidance 

document is also available upon request 

from the Center for Devices and 

Radiological Health, Division of Small 

Manufacturers Assistance (HFZ–220), 

1350 Piccard Dr., Rockville, MD 20850, 

FAX 301–443–8818’’ with ‘‘Additional 

information on FDA policies and 

procedures, as well as links to PMA 

guidance documents, is available on the 

Internet at http://www.fda.gov/cdrh/ 

devadvice/pma/.’’

6. FDA is revising § 820.1(e) and 

replacing ‘‘Division of Small 


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Manufacturers Assistance (HFZ–220), 

1350 Piccard Dr., Rockville, MD 20850, 

U.S.A., telephone 1–800–638–2041 or 

1–301–443–6597, FAX 301–443–8818’’

with ‘‘Division of Small Manufacturers, 

International and Consumer Assistance 

(HFZ–220), 1350 Piccard Dr., Rockville, 

MD 20850, U.S.A., telephone 1–800–

638–2041 or 240–276–3150, FAX 240–

276–3151.’’

7. FDA is revising § 821.2(c) and 

removing the words ‘‘and Surveillance.’’

8. FDA is revising § 822.7(b) and 

replacing ‘‘(www.fda.gov/cdrh/ 

resolvingdisputes), and from the CDRH 

Facts-on-Demand system (800–899–

0381 or 301–827–0111)’’ with ‘‘(http:// 

www.fda.gov/cdrh/ombudsman/ 

dispute.html).’’

9. FDA is revising § 822.15 and 

replacing ‘‘You may obtain guidance 

regarding dispute resolution procedures 

from the Center for Devices and 

Radiological Health’s (CDRH) Web site 

(www.fda.gov/cdrh/resolvingdisputes/ 

ombudsman.html) and from the CDRH 

Facts-on-Demand system (800–899–

0381 or 301–827–0111, document 

number 1121)’’ with ‘‘You may obtain 

guidance regarding dispute resolution 

procedures from the Center for Devices 

and Radiological Health’s (CDRH’s) Web 

site (www.fda.gov/cdrh/ombudsman/).’’

10. FDA is revising § 822.22(b) and 

replacing ‘‘You may obtain guidance 

documents that discuss these 

mechanisms from the CDRH Web site 

and from the CDRH Facts-on-Demand 

System (800–899–0381 or 301–827–

0111)’’ with ‘‘You may obtain guidance 

documents that discuss these 

mechanisms from the Center for Devices 

and Radiological Health’s (CDRH’s) Web 

site.’’

11. FDA is revising § 874.4420 and 

replacing ‘‘tonsil suction tub’’ with 

‘‘tonsil suction tube.’’

12. FDA is revising § 874.4420 and 

replacing ‘‘ear suction tub’’ with ‘‘ear 

suction tube.’’

13. FDA is revising the section title in 

§ 886.1090 and replacing ‘‘Haidlinger’’

with ‘‘Haidinger.’’

14. FDA is revising § 886.1090(a) and 

replacing ‘‘Haidlinger’’ with 

‘‘Haidinger.’’

15. FDA is revising § 1002.7 and 

replacing ‘‘shall be addressed to the 

Center for Devices and Radiological 

Health, Electronic Product Reports, 

Office of Compliance (HFZ–307), 2098 

Gaither Rd., Rockville, MD 20850’’ with 

‘‘shall be addressed to the Center for 

Devices and Radiological Health, ATTN: 

Electronic Product Reports, Radiological 

Health Document Control (HFZ–309), 

Office of Communication, Education, 

and Radiation Programs, 9200 Corporate 

Blvd, Rockville, MD 20850. 

16. FDA is revising § 1002.10 and 

replacing ‘‘Center for Devices and 

Radiological Health, Electronic Product 

Reports, Office of Compliance (HFZ–

307), 2098 Gaither Rd., Rockville, MD 

20850’’ with ‘‘Center for Devices and 

Radiological Health, ATTN: Electronic 

Product Reports, Radiological Health 

Document Control (HFZ–309), Office of 

Communication, Education, and 

Radiation Programs, 9200 Corporate 

Blvd, Rockville, MD 20850.’’

17. FDA is revising § 1002.20(b) and 

replacing ‘‘Director, Center for Devices 

and Radiological Health, 5600 Fishers 

Lane, Rockville, MD 20857’’ with 

‘‘Center for Devices and Radiological 

Health, ATTN: Accidental Radiation 

Occurrence Reports (HFZ–240), Office 

of Communication, Education, and 

Radiation Programs, 9200 Corporate 

Boulevard, Rockville, MD 20850.’’

18. FDA is revising § 1002.50(c)(3) 

and replacing ‘‘Office of Compliance 

(HFZ–307)’’ with ‘‘Office of 

Communication, Education, and 

Radiation Programs (HFZ–240).’’

19. FDA is revising § 1005.11 and 

replacing ‘‘5600 Fishers Lane, Rockville, 

MD 20857’’ with ‘‘(HFZ–204), 9200 

Corporate Blvd., Rockville, MD 20857.’’

20. FDA is revising § 1005.25(b) and 

adding ‘‘(HFZ–240).’’

21. FDA is revising § 1020.30(c) and 

replacing ‘‘Office of Compliance and 

Surveillance’’ with ‘‘Office of 

Communication, Education, and 

Radiation Programs.’’

II. Environmental Impact 

The agency has determined under 21 

CFR 25.30(i) that this final rule is of a 

type that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

was required. 

III. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

the Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Public Law 104–4). 

Executive Order 12866 directs agencies 

to assess all costs and benefits of 

available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

agency believes that this final rule is not 

a significant regulatory action under the 

Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because this rule corrects only 

typographical and nonsubstantive errors 

in existing regulations and does not 

change in any way how devices are 

regulated, the agency certifies that the 

final rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $122 

million, using the most current (2005) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

IV. Paperwork Reduction Act of 1995 

FDA has determined that this final 

rule contains no collections of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

V. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

VI. The Technical Amendments 

This rule updates and corrects 

existing regulations to ensure accuracy 

and clarity. This administrative action is 

limited to correcting typographical 

errors; updating changes in addresses, 

web site locations, and telephone 

numbers; and clarifying regulation 

terminology. It makes no changes in 

substantive requirements. 

For the effective date of this final rule 

see EFFECTIVE DATE. Because this final 


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rule is an administrative action, FDA 

has determined that it has no 

substantive impact on the public. It 

imposes no costs, and merely makes 

technical administrative changes in the 

Code of Federal Regulations (CFR) for 

the convenience of the public. FDA, 

therefore, for good cause, finds under 5 

U.S.C. 553(b)(3)(B) and (d)(3) that notice 

and public comment are unnecessary. 

List of Subjects 

21 CFR Part 803 

Imports, Medical devices, Reporting 

and recordkeeping requirements. 

21 CFR Part 814 

Administrative practice and 

procedure, Confidential business 

information, Medical devices, Medical 

research, Reporting and recordkeeping 

requirements. 

21 CFR Part 820 

Medical devices, Reporting and 

recordkeeping requirements. 

21 CFR Part 821 

Imports, Medical devices, Reporting 

and recordkeeping requirements. 

21 CFR Part 822 

Medical devices, Reporting and 

recordkeeping requirements. 

21 CFR Part 874 

Medical devices. 

21 CFR Part 886 

Medical devices, Ophthalmic goods 

and services. 

21 CFR Part 1002 

Electronic products, Radiation 

protection, Reporting and recordkeeping 

requirements. 

21 CFR Part 1005 

Administrative practice and 

procedure, Electronic products, Imports, 

Radiation protection, Surety bonds. 

21 CFR Part 1020 

Electronic products, Medical devices, 

Radiation protection, Reporting and 

recordkeeping requirements, Television, 

X-rays. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act, and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR parts 803, 

814, 820, 821, 822, 874, 886, 1002, 1005, 

and 1020 are amended as follows: 

PART 803—MEDICAL DEVICE 

REPORTING 

■ 1. The authority section for part 803 

continues to read as follows: 

Authority: 21 U.S.C. 352, 360, 360i, 360j, 

371, 374. 

■ 2. Section 803.11 is revised to read as 

follows: 

§ 803.11 What form should I use to submit 

reports of individual adverse events and 

where do I obtain these forms? 

If you are a user facility, importer, or 

manufacturer, you must submit all 

reports of individual adverse events on 

FDA MEDWATCH Form 3500A or in an 

electronic equivalent as approved under 

§ 803.14. You may obtain this form and 

all other forms referenced in this section 

from any of the following: 

(a) The Consolidated Forms and 

Publications Office, Beltsville Service 

Center, 6351 Ammendale Rd., Landover, 

MD 20705; 

(b) FDA, MEDWATCH (HF–2), 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–7240; 

(c) Division of Small Manufacturers, 

International, and Consumer Assistance, 

Office of Communication, Education, 

and Radiation Programs, Center for 

Devices and Radiological Health (CDRH) 

(HFZ–220), 1350 Piccard Dr. Rockville, 

MD 20850, by e-mail: 

DSMICA@CDRH.FDA.GOV, or FAX: 

240–276–3151; 

(d) On the Internet at http:// 

www.fda.gov/medwatch/getforms.htm. 

■ 3. In § 803.21, paragraph (a) is revised 

to read as follows: 

§ 803.21 Where can I find the reporting 

codes for adverse events that I use with 

medical device reports? 

(a) The MEDWATCH Medical Device 

Reporting Code Instruction Manual 

contains adverse event codes for use 

with FDA Form 3500A. You may obtain 

the coding manual from CDRH’s Web 

site at http://www.fda.gov/cdrh/mdr/ 

mdr-forms.html; and from the Division 

of Small Manufacturers, International, 

and Consumer Assistance, Center for 

Devices and Radiological Health, 1350 

Piccard Dr., Rockville, MD 20850, FAX: 

240–276–3151, or e-mail to 

DSMICA@CDRH.FDA.GOV. 

* * * * * 

PART 814—PREMARKET APPROVAL 

OF MEDICAL DEVICES 

■ 4. The authority section for part 814 

continues to read as follows: 

Authority: 21 U.S.C. 351, 352, 353, 360, 

360c–360j, 371, 372, 373, 374, 375, 379, 379e, 

381. 

■ 5. In § 814.20, paragraph (g) is revised 

to read as follows: 

§ 814.20 Application. 

* * * * * 

(g) Additional information on FDA 

policies and procedures, as well as links 

to PMA guidance documents, is 

available on the Internet at http:// 

www.fda.gov/cdrh/devadvice/pma/. 

* * * * * 

PART 820—QUALITY SYSTEMS 

REGULATION 

■ 6. The authority section for part 820 

continues to read as follows: 

Authority: 21 U.S.C. 351, 352, 360, 360c, 

360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 

381, 383. 

■ 7. In § 820.1, paragraph (e)(1) is 

revised to read as follows: 

§ 820.1 Scope. 

* * * * * 

(e) Exemptions or variances. (1) Any 

person who wishes to petition for an 

exemption or variance from any device 

quality system requirement is subject to 

the requirements of section 520(f)(2) of 

the act. Petitions for an exemption or 

variance shall be submitted according to 

the procedures set forth in § 10.30 of 

this chapter, the FDA’s administrative 

procedures. Guidance is available from 

the Center for Devices and Radiological 

Health, Division of Small 

Manufacturers, International and 

Consumer Assistance (HFZ–220), 1350 

Piccard Dr., Rockville, MD 20850, 

U.S.A., telephone 1–800–638–2041 or 

240–276–3150, FAX 240–276–3151. 

* * * * * 

PART 821—MEDICAL DEVICE 

TRACKING REQUIREMENTS 

■ 8. The authority section for part 821 

continues to read as follows: 

Authority: 21 U.S.C. 331, 351, 352, 360, 

360e, 360h, 360i, 371, 374. 

■ 9. In § 821.2, paragraph (c) is revised 

to read as follows: 

§ 821.2 Exemptions and variances. 

* * * * * 

(c) An exemption or variance is not 

effective until the Director, Office of 

Compliance, CDRH, approves the 

request under § 10.30(e)(2)(i) of this 

chapter. 

PART 822—POSTMARKET 

SURVEILLANCE 

■ 10. The authority section for part 822 

continues to read as follows: 

Authority: 21 U.S.C. 331, 352, 360i, 360l, 

371, 374. 

■ 11. In § 822.7, paragraph (b) is revised 

to read as follows: 

§ 822.7 What should I do if I do not agree 

that postmarket surveillance is 

appropriate? 

* * * * * 


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(b) You may obtain guidance 

documents that discuss these 

mechanisms from the Center for Devices 

and Radiological Health’s (CDRH’s) Web 

site (http://www.fda.gov/cdrh/ 

ombudsman/dispute.html). 

■ 12. Section 822.15 is revised to read 

as follows: 

§ 822.15 How long must I conduct 

postmarket surveillance of my device? 

The length of postmarket surveillance 

will depend on the postmarket 

surveillance question identified in our 

order. We may order prospective 

surveillance for a period up to 36 

months; longer periods require your 

agreement. If we believe that a 

prospective period of greater than 36 

months is necessary to address the 

surveillance question, and you do not 

agree, we will use the Medical Devices 

Dispute Resolution Panel to resolve the 

matter. You may obtain guidance 

regarding dispute resolution procedures 

from the Center for Devices and 

Radiological Health’s (CDRH’) Web site 

(www.fda.gov/cdrh/ombudsman/). The 

36-month period refers to the 

surveillance period, not the length of 

time from the issuance of the order. 

■ 13. In § 822.22, paragraph (b) is 

revised to read as follows: 

§ 822.22 What recourse do I have if I do 

not agree with your decision? 

* * * * * 

(b) You may obtain guidance 

documents that discuss these 

mechanisms from the Center for Devices 

and Radiological Health’s (CDRH’s) Web 

site. 

PART 874—EAR, NOSE, AND THROAT 

DEVICES 

■ 14. The authority section for part 874 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

■ 15. In § 874.4420, paragraph (a) is 

revised to read as follows: 

§ 874.4420 Ear, nose, and throat manual 

surgical instrument. 

(a) Identification. An ear, nose, and 

throat manual surgical instrument is one 

of a variety of devices intended for use 

in surgical procedures to examine or 

treat the bronchus, esophagus, trachea, 

larynx, pharynx, nasal and paranasal 

sinus, or ear. This generic type of device 

includes the esophageal dilator; tracheal 

bistour (a long, narrow surgical knife); 

tracheal dilator; tracheal hook; laryngeal 

injection set; laryngeal knife; laryngeal 

saw; laryngeal trocar; laryngectomy 

tube; adenoid curette; adenotome; metal 

tongue depressor; mouth gag; oral 

screw; salpingeal curette; tonsillectome; 

tonsil guillotine; tonsil screw; tonsil 

snare; tonsil suction tube; tonsil 

suturing hook; antom reforator; ethmoid 

curette; frontal sinus-rasp; nasal curette; 

nasal rasp; nasal rongeur; nasal saw; 

nasal scissors; nasal snare; sinus 

irrigator; sinus trephine; ear curette; ear 

excavator; ear rasp; ear scissor, ear 

snare; ear spoon; ear suction tube; 

malleous ripper; mastoid gauge; 

microsurgical ear chisel; myringotomy 

tube inserter; ossici holding clamp; 

sacculotomy tack inserter; vein press; 

wire ear loop; microrule; mirror; 

mobilizer; ear, nose, and throat punch; 

ear, nose and throat knife; and ear, nose, 

and throat trocar. 

* * * * * 

PART 886—OPHTHALMIC DEVICES 

■ 16. The authority section for part 886 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

■ 17. In § 886.1090, the section title and 

paragraph (a) are revised to read as 

follows: 

§ 886.1090 Haidinger brush. 

(a) Identification. A Haidinger brush 

is an AC-powered device that provides 

two conical brushlike images with 

apexes touching which are viewed by 

the patient through a Nicol prism and 

intended to evaluate visual function. It 

may include a component for measuring 

macular integrity. 

* * * * * 

PART 1002—RECORDS AND 

REPORTS 

■ 18. The authority section for part 1002 

continues to read as follows: 

Authority: 21 U.S.C. 352, 360, 360i, 360j, 

360hh–360ss, 371, 374. 

■ 19. In § 1002.7, the introductory text 

is revised to read as follows: 

§ 1002.7 Submission of data and reports. 

All submissions such as reports, test 

data, product descriptions, and other 

information required by this part, or 

voluntarily submitted to the Director, 

Center for Devices and Radiological 

Health, shall be filed with the number 

of copies as prescribed by the Director, 

Center for Devices and Radiological 

Health, and shall be signed by the 

person making the submission. The 

submissions required by this part shall 

be addressed to the Center for Devices 

and Radiological Health, ATTN: 

Electronic Product Reports, Radiological 

Health Document Control (HFZ–309), 

Office of Communication, Education, 

and Radiation Programs, 9200 Corporate 

Blvd., Rockville, MD 20850. 

* * * * * 

■ 20. In § 1002.10, the introductory text 

is revised to read as follows: 

§ 1002.10 Product reports. 

Every manufacturer of a product or 

component requiring a product report as 

set forth in table 1 of § 1002.1 shall 

submit a product report to the Center for 

Devices and Radiological Health, ATTN: 

Electronic Product Reports, Radiological 

Health Document Control (HFZ–309), 

Office of Communication, Education, 

and Radiation Programs, 9200 Corporate 

Blvd., Rockville, MD 20850, prior to the 

introduction of such product into 

commerce. The report shall be distinctly 

marked ‘‘Radiation Safety Product 

Report of (name of manufacturer)’’ and 

shall: 

* * * * * 

■ 21. In § 1002.20, paragraph (b) is 

revised to read as follows: 

§ 1002.20 Reporting of accidental radiation 

occurrences. 

* * * * * 

(b) Such reports shall be addressed to 

the Center for Devices and Radiological 

Health, ATTN: Accidental Radiation 

Occurrence Reports (HFZ–240), Office 

of Communication, Education, and 

Radiation Programs, 9200 Corporate 

Blvd., Rockville, MD 20850, and the 

reports and their envelopes shall be 

distinctly marked ‘‘Report on 1002.20’’

and shall contain all of the following 

information where known to the 

manufacturer: 

(1) The nature of the accidental 

radiation occurrence; 

(2) The location at which the 

accidental radiation occurrence 

occurred; 

(3) The manufacturer, type, and 

model number of the electronic product 

or products involved; 

(4) The circumstances surrounding 

the accidental radiation occurrence, 

including causes; 

(5) The number of persons involved, 

adversely affected, or exposed during 

the accidental radiation occurrence, the 

nature and magnitude of their exposure 

and/or injuries and, if requested by the 

Director, Center for Devices and 

Radiological Health, the names of the 

persons involved; 

(6) The actions, if any, which may 

have been taken by the manufacturer, to 

control, correct, or eliminate the causes 

and to prevent reoccurrence; and 


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Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Rules and Regulations 17401 

(7) Any other pertinent information 

with respect to the accidental radiation 

occurrence. 

* * * * * 

■ 22. In § 1002.50, paragraph (c)(3) is 

revised to read as follows: 

§ 1002.50 Special exemptions. 

* * * * * 

(c) * * * 

(3) Such conditions as are deemed 

necessary to protect the public health 

and safety. Copies of exemptions shall 

be available upon request from the 

Center for Devices and Radiological 

Health, Office of Communication, 

Education, and Radiation Programs 

(HFZ–240), 9200 Corporate Blvd., 

Rockville, MD 20850. 

* * * * * 

PART 1005—IMPORTATION OF 

ELECTRONIC PRODUCTS 

■ 23. The authority section for part 1005 

continues to read as follows: 

Authority: 42 U.S.C. 263d, 263h. 

■ 24. Section 1005.11 is revised to read 

as follows: 

§ 1005.11 Payment for samples. 

The Department of Health and Human 

Services will pay for all import samples 

of electronic products rendered 

unsalable as a result of testing, or will 

pay the reasonable costs of repackaging 

such samples for sale, if the samples are 

found to be in compliance with the 

requirements of the Radiation Control 

for Health and Safety Act of 1968. 

Billing for reimbursement shall be made 

by the owner or consignee to the Center 

for Devices and Radiological Health 

(HFZ–204), 9200 Corporate Blvd., 

Rockville, MD 20857. Payment for 

samples will not be made if the sample 

is found to be in violation of the Act, 

even though subsequently brought into 

compliance pursuant to terms specified 

in a notice of permission issued under 

§ 1005.22. 

■ 25. In § 1005.25, paragraph (b) is 

revised to read as follows: 

§ 1005.25 Service of process on 

manufacturers. 

* * * * * 

(b) A manufacturer designating an 

agent must address the designation to 

the Center for Devices and Radiological 

Health (HFZ–240), 9200 Corporate 

Blvd., Rockville, MD 20850. It must be 

in writing and dated; all signatures must 

be in ink. The designation must be made 

in the legal form required to make it 

valid and binding on the manufacturer 

under the laws, corporate bylaws, or 

other requirements governing the 

making of the designation by the 

manufacturer at the place and time 

where it is made, and the persons or 

person signing the designation shall 

certify that it is so made. The 

designation must disclose the 

manufacturer’s full legal name and the 

name(s) under which the manufacturer 

conducts the business, if applicable, the 

principal place of business, and mailing 

address. If any of the products of the 

manufacturer do not bear his legal 

name, the designation must identify the 

marks, trade names, or other 

designations of origin which these 

products bear. The designation must 

provide that it will remain in effect until 

withdrawn or replaced by the 

manufacturer and shall bear a 

declaration of acceptance duly signed 

by the designated agent. The full legal 

name and mailing address of the agent 

must be stated. Until rejected by the 

Secretary, designations are binding on 

the manufacturer even when not in 

compliance with all the requirements of 

this section. The designated agent may 

not assign performance of his function 

under the designation to another. 

* * * * * 

PART 1020—PERFORMANCE 

STANDARDS FOR IONIZING 

RADIATION EMITTING PRODUCTS 

■ 26. The authority section for part 1020 

continues to read as follows: 

Authority: 21 U.S.C. 351, 352, 360e–360j, 

360gg–360ss, 371, 381. 

■ 27. In § 1020.30, paragraph (c) is 

revised to read as follows: 

§ 1020.30 Diagnostic x-ray systems and 

their major components. 

* * * * * 

(c) Manufacturers’ responsibility. 

Manufacturers of products subject to 

§§ 1020.30 through 1020.33 shall certify 

that each of their products meet all 

applicable requirements when installed 

into a diagnostic x-ray system according 

to instructions. This certification shall 

be made under the format specified in 

§ 1010.2 of this chapter. Manufacturers 

may certify a combination of two or 

more components if they obtain prior 

authorization in writing from the 

Director of the Office of 

Communication, Education, and 

Radiation Programs of the Center for 

Devices and Radiological Health. 

Manufacturers shall not be held 

responsible for noncompliance of their 

products if that noncompliance is due 

solely to the improper installation or 

assembly of that product by another 

person; however, manufacturers are 

responsible for providing assembly 

instructions adequate to assure 

compliance of their components with 

the applicable provisions of §§ 1020.30 

through 1020.33. 

* * * * * 

Dated: March 28, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–6290 Filed 4–6–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Parts 1300 and 1313 

[Docket No. DEA–292I] 

RIN 1117–AB06 

Implementation of the Combat 

Methamphetamine Epidemic Act of 

2005; Notice of Transfers Following 

Importation or Exportation 

AGENCY: Drug Enforcement 

Administration (DEA), Justice. 

ACTION: Interim Final Rule with Request 

for Comment. 

SUMMARY: This regulation implements 

section 716 of the Combat 

Methamphetamine Epidemic Act 

(CMEA) of 2005 (21 U.S.C. 971 as 

amended), which was enacted on March 

9, 2006. DEA is amending its regulations 

to require additional reporting for 

import, export, and international 

transactions involving all List I and List 

II chemicals. This rule implements 

section 716 of the CMEA which extends 

current reporting requirements for 

importations, exportations, and 

international transactions involving List 

I and List II chemicals. 

DATES: This rule is effective May 9, 

2007. Written comments must be 

postmarked, and electronic comments 

must be sent, on or before May 9, 2007. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–292’’ on all written and 

electronic correspondence. Written 

comments being sent via regular mail 

should be sent to the Deputy Assistant 

Administrator, Office of Diversion 

Control, Drug Enforcement 

Administration, Washington, DC 20537, 

Attention: DEA Federal Register 

Representative/ODL. Written comments 

sent via express mail should be sent to 

DEA Headquarters, Attention: DEA 

Federal Register Representative/ODL, 

2401 Jefferson-Davis Highway, 

Alexandria, VA 22301. Comments may 

be directly sent to DEA electronically by 

sending an electronic message to 

dea.diversion.policy@usdoj.gov. 


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